BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3003868 · Received March 14, 2013

    Report

    Report Number
    2134265-2013-01429
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE IS COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE A FAILURE ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A BALLOON RUPTURE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE CALCIFIED AND SEVERELY TORTUOUS PROXIMAL RIGHT CORONARY ARTERY (RCA) EXTENDING TO THE DISTAL RCA. PRE-IVUS AND PRE-DILATION WERE PERFORMED. A 3.0X38 PROMUS ELEMENT STENT WAS DEPLOYED IN THE DISTAL RCA. THE 3.5X32MM PROMUS ELEMENT PLUS CORONARY DRUG-ELUTING STENT DELIVERY SYSTEM (SDS) WAS THEN DEPLOYED IN THE MID RCA AT 11ATMS. POST-DILATION WAS PERFORMED WITH THE BALLOON OF THE SDS. DURING THE FIRST INFLATION, THE BALLOON RUPTURED AT 16 ATMS. THE DEVICE WAS REMOVED INTACT AND THE STENT WAS POST-DIALTED WITH A NON BSC 3.5 BALLOON. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107488 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493918432350 15539508

    Patients

    Seq Age Sex Outcome Treatment
    1